Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin - LARVOL DELTA

Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States. (PubMed, J Am Soc Nephrol) - "In patients with DD-CKD, safety (vis-à-vis MACE) and efficacy (vis-à-vis change in hemoglobin) of vadadustat and darbepoetin alfa were similar when stratified by region (US versus non-US). In US patients with NDD-CKD, safety and efficacy of vadadustat and darbepoetin alfa were similar."

Journal • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Myocardial Infarction

Comparative efficacy of epoetin alfa vs. darbepoetin in children with chronic kidney disease: a systematic review, meta-analysis and cost-effectiveness analysis. (PubMed, J Nephrol) - "rHuEPO is the most cost-effective initial anemia treatment in pediatric CKD. However, transitioning to DA may be considered for patients who do not achieve adequate Hb response. The small number of randomized controlled trials (RCTs), variability in dose conversion, and study heterogeneity may limit generalizability."

HEOR • Journal • Retrospective data • Review • Chronic Kidney Disease • Hematological Disorders • Nephrology • Pediatrics • Renal Disease

Vascular Access Thrombosis Events in Patients With Dialysis-Dependent CKD Treated With Vadadustat or Darbepoetin Alfa: The INNO2VATE Trial Program. (PubMed, Kidney Med) - P3 | "In this secondary analysis of the INNO2VATE program in patients with DD-CKD and CKD-related anemia receiving hemodialysis, first VAT rates were numerically higher among patients treated with vadadustat versus darbepoetin alfa but statistically not different. The rates of first and recurrent VAT events were similar between treatment groups."

Clinical • Journal • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombosis

Darbepoetin alfa use in trauma and acute care surgery patients who abstain from blood products: A case series and discussion. (PubMed, Am J Health Syst Pharm) - "The use of darbepoetin alfa appeared to be a therapeutic option to treat anemia in trauma and acute care surgery patients who abstain from blood products. Future studies are needed to compare epoetin alfa and darbepoetin alfa."

Journal • Cardiovascular • Hematological Disorders • Myocardial Infarction

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) - P1/2 | N=13 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=41 ➔ 13

Enrollment change • Enrollment closed • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Mechanical Support Escalation to Bridge Anemic Jehovah's Witness to Cardiac Transplantation (ISHLT 2025) - "He was upgraded to Impella 5.5® (Abiomed, Danvers, MA) and treated with intravenous iron and Darbepoetin Alfa with subcutaneous heparin. Prior case reports have elaborated on the selective use of erythropoiesis stimulation in tMCS. To our knowledge, this is the first case report that describes efficacy of this strategy in a patient with decompensation and blood loss anemia requiring tMCS escalation as bridge to OHT."

Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Thrombosis • Transplantation

Protocol for Comparing Hemoglobin Control between Darbepoetin Alfa and Short-acting rHuEPO in Maintenance Hemodialysis Patients (ChiCTR) - P4 | N=410 | Not yet recruiting | Sponsor: Shenzhen Second People's hospital; Shenzhen Second People's hospital

New P4 trial • Anemia • Hematological Disorders • Renal Disease

Cardiovascular Risk in Patients With DD-CKD Randomized to Vadadustat vs Darbepoetin Alfa With or Without Cardiovascular Disease (NKF-SCM 2025) - "In patients with a history of CV disease, the hazard ratio (HR) for MACE was 0.95 (95% CI: 0.80, 1.13) and for patients without a history of CV disease, HR for MACE was 1.00 (95% CI: 0.77, 1.30). Secondary safety outcomes were similar ( Figure ).Conclusion CV risk with VADA was similar to DA irrespective of baseline CV disease history."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Hematological Disorders • Myocardial Infarction

Vadadustat for Treatment of Anemia in Older vs Younger Patients With Dialysis-Dependent-CKD (NKF-SCM 2025) - "In ph3 trials of patients with DD-CKD (INNO 2 VATE), VADA was noninferior to darbepoetin alfa (DA) in time to first major adverse cardiovascular event (MACE: a composite of all-cause mortality, nonfatal MI, and nonfatal stroke) and hemoglobin (Hb) correction/maintenance. NI for both primary safety (MACE) and efficacy was met in each of the 2 age strata. In patients <65y, incidence of TEAEs was 87% vs 88%, and ≥65y it was 89% vs 91% in VADA vs DA, respectively.Conclusion In post hoc analyses, safety and efficacy of VADA were noninferior to DA irrespective of age stratum."

Clinical • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders

Pharmacokinetic/Pharmacodynamic Parameters of NNG-DEPO (Stimus) With Aranesp® (Amgen) in Treatment of Anemia in CKD Patients on Dialysis (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company | Active, not recruiting ➔ Completed

Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

A Study to Compare Efficacy and Safety of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (CKD) (clinicaltrials.gov) - P3 | N=214 | Completed | Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company | Active, not recruiting ➔ Completed

Trial completion • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Efficacy and safety of daprodustat versus darbepoetin alfa in the treatment of anemia in chronic renal failure: Systematic review and meta-analysis of randomized controlled trials. (PubMed, J Pharmacol Sci) - "DPD is not inferior to DBPA in the treatment of anemia in chronic renal failure."

Clinical • Journal • Retrospective data • Review • Anemia • Chronic Kidney Disease • Hematological Disorders • Renal Disease

Effects of Darbepoetin Alfa and Ferric Derisomaltose Plus Darbepoetin Alfa in Functional Iron-Deficiency Anemia. (PubMed, Int J Mol Sci) - "Patients with chemotherapy-induced FIDA in Group I receiving ferric derisomaltose plus darbepoetin alfa showed higher hemoglobin levels, transferrin saturation, and ferritin levels compared to those in Group II, treated with darbepoetin alfa alone. In cancer patients with FIDA, the prognosis of anemia treatment was better in the ferric derisomaltose plus darbepoetin alfa combination group than in the group receiving darbepoetin alfa monotherapy."

Journal • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Oncology

MERKEL CELL CARCINOMA: A RARE SIDE EFFECT OF RUXOLITINIB USED IN MYELOFIBROSIS TREATMENT (SCCM 2025) - "Initial treatment with Darbepoetin alfa was switched to Ruxolitinib due to inadequate response...Ruxolitinib was discontinued and started on Pacritinib...Our case also creates a pertinent link between the use of Ruxolitinib and the development of this aggressive rare neuroendocrine tumor. This warrants the offering of periodic skin examination to patients receiving Ruxolitinib for hematological malignancy."

Adverse events • Anemia • Atrial Fibrillation • Cardiovascular • Endocrine Cancer • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Ischemic stroke • Merkel Cell Carcinoma • Myelodysplastic Syndrome • Myelofibrosis • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • ASXL1 • CD20 • NKX2-1 • U2AF1

Vadadustat (Vafseo) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Cresp®: transforming the landscape of chemotherapy-induced anemia - a comprehensive retrospective real-world analysis in 523 Indian patients. (PubMed, Front Oncol) - "DA demonstrates impressive efficacy and safety in managing CIA, leading to substantial improvements in mean hemoglobin levels in palliative setting. This has the potential to reduce the need for blood transfusions and enhance the quality of life for patients."

Journal • Real-world evidence • Retrospective data • Anemia • Cardiovascular • Chemotherapy-Induced Anemia • Fatigue • Hematological Disorders • Hypertension • Oncology • Pulmonary Disease • Solid Tumor • Thrombosis

Estimation of protein aggregates in Darbepoetin alfa formulations by developing a single validated analytical method. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Additionally, stress testing of samples was done to simulate the after-production exposure and stability assessment. The results demonstrated that the method for analysing aggregates in darbepoetin is complying the criteria of being sensitive, specific, accurate, robust and reliable."

Journal • Chronic Kidney Disease • Nephrology • Oncology • Renal Disease

Darbepoetin alfa enhances exercise performance in trained mice in a sex-specific manner. (PubMed, J Pharmacol Sci) - "These results revealed the sex-specific enhancing effect of DPO on exercise performance in trained mice. Enhanced exercise performance did not appear to require female sex hormones and may not be due to direct effects on skeletal muscles."

Journal • Preclinical • PPARGC1A

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "Our established products, which consist of EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions."

Sales • Chronic Kidney Disease • Hematological Disorders • Neutropenia

A Simple Rapid HPLC-UV Method for Assessing C-Terminal Arginine Content in Darbepoetin Alfa. (PubMed, Biomed Chromatogr) - "All the stages of the described method (from the sample extraction to obtaining a chromatographic profile) take about 5 h. The proposed approach will be useful for laboratories developing a technology for producing recombinant darbepoetin alfa, to assess the quality of the product, and for subsequent optimization of the production process."

Journal

REGIME: Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes (clinicaltrials.gov) - P3 | N=360 | Completed | Sponsor: Barts & The London NHS Trust | Unknown status ➔ Completed

Trial completion • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Efficacy and safety of daprodustat in patients on peritoneal dialysis in the ASCEND-D trial. (PubMed, Nephrol Dial Transplant) - P3 | "This subgroup analysis of the ASCEND-D trial demonstrated comparable efficacy and safety of daprodustat versus darbepoetin alfa in PD patients, supporting its use in the treatment of anemia in these patients."

Journal • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial primary completion date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

VOICE: Vafseo Outcomes In-Center Experience (clinicaltrials.gov) - P3 | N=2200 | Recruiting | Sponsor: USRC Kidney Research | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

N-terminal pro-brain natriuretic peptide and cardiorenal outcome in patients with anaemia in chronic kidney disease. (PubMed, ESC Heart Fail) - "NT-proBNP provides prognostic insights into cardiovascular and renal outcomes among patients with advanced chronic kidney disease experiencing anaemia."

Journal • Acute Coronary Syndrome • Anemia • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Hematological Disorders • Nephrology • Renal Disease • Transplantation • NPPB